MONDAY, Dec. 8, 2003 (HealthDayNews) -- Janssen Pharmaceutica says its schizophrenia drug Risperdal has been approved by the U.S. Food and Drug Administration for the treatment of bipolar disorder, often called manic depression.
The drug was approved to be used alone or with standard treatments like lithium or valproate for bipolar I disorder, its more severe form. Affecting 2 million people in the United States, the disorder is characterized by dramatic high and low mood swings.
The manic episodes, with symptoms including excessive excitement and hyperactivity, can lead to delusional thinking and dangerous risk-taking behavior. And the condition's depressive state can lead to suicide. Nearly 40 percent of people with untreated bipolar disorder abuse alcohol and drugs, the company says.
In three clinical trials in which the drug was used alone or in combination with standard therapies, patients saw significantly greater symptom improvement than those who took a non-medicinal placebo.
The drug's label includes a warning that it could cause abnormal heart rhythm, especially among patients with existing heart conditions. Common side effects include muscle tremors and stiffness, sleepiness, nausea, and increased saliva.
Risperdal has been available in the United States since 1994 for the treatment of schizophrenia.